Prescription Drugs

Failed Tablet/Capsule Specification; out of specification for tablet weight

Lack of Sterility Assurance

Failed Impurities/Degradation Specifications: high out of specification results for related compound D.

Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.